U.S. FDA Unveils AI Tool Elsa for Clinical Review, Internal Writing, and Data Processing

On June 2, 2025, the United States Food and Drug Administration (FDA) announced on its official website the launch of a new generative artificial intelligence (AI) tool named Elsa. The tool is designed to assist various professionals, including scientific reviewers and researchers, in working more efficiently. This innovative tool aims to modernize agency functions and utilize AI capabilities to better serve the American public.

FDA Director Marty Makary said:

"After collaborating with FDA scientific reviewers on a highly successful pilot project, I developed a proactive timeline to implement artificial intelligence agency-wide by June 30. Thanks to the collaboration of internal experts from our various centers, today's launch of Elsa was completed ahead of schedule and within budget."

Elsa is built in a highly secure GovCloud environment, providing FDA employees with a secure platform to access internal files while ensuring all information remains within the agency. These models will not use data submitted by regulated industries for training, thereby protecting the sensitive research and data handled by FDA employees.

FDA Chief Artificial Intelligence Officer Jeremy Walsh stated:

"The release of Elsa marks the arrival of the FDA's artificial intelligence era. Artificial intelligence is no longer a distant promise, but a powerful force that can enhance and optimize the performance and potential of every employee. As we learn how employees are utilizing this tool, our development team will be able to continuously expand its capabilities and grow based on the needs of employees and organizations."

 

The organization has been using Elsa to expedite the review of clinical trial protocols, shorten the time needed for scientific evaluation, and identify high-priority research targets.Elsa is an AI tool based on a large language model, designed to assist in reading, writing, and summarizing. It can summarize adverse events to support safety assessments, compare tags more quickly, and generate code to help develop non-clinical applications for databases.

The FDA stated that the launch of Elsa is the first step in its overall AI journey. As this tool matures, the FDA plans to integrate more AI technologies into various processes, such as data processing and generative AI functions, to further support the FDA's mission.